The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.

Device Description

The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.

AI/ML Overview

The provided text describes a medical device, the "3 In 1" I.V. Administration Set, and its 510(k) summary for clearance. However, it does not detail a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for an AI/ML device would.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K925465). This is a different type of validation process.

Here's an analysis based on the information provided, addressing your requested points where applicable, and noting where the information is not present for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an IV administration set), the "acceptance criteria" are generally tied to demonstrating that the device performs as intended and is as safe and effective as a legally marketed predicate device. The performance data presented are primarily engineering bench tests to ensure the physical integrity and functionality of the set.

Acceptance Criteria Category (Implied by Submission)	Reported Device Performance (from text)
Intended Use Equivalence	Identical to predicate device (K925465)
Component Similarity	Similar components and materials to predicate device
Biocompatibility	Performed (implies met relevant standards, though specific results not detailed)
Bench Testing - Physical Integrity	Pull testing, pressure testing, joint strength testing, and drop testing performed (implies met internal specifications, though exact criteria/results not detailed)
Sterilization/Residuals	Performed (Sterile via EO, implies met standards, though specifics not detailed)
Labeling Similarity	Similar to predicate device
Packaging Similarity	Similar to predicate device
Sterilization Method	Identical to predicate device (Sterile via EO)
Materials Used	Materials are used in legally marketed devices under comparable conditions (implies generally accepted and safe)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. For bench testing of physical properties, specific sample sizes are typically used for each test (e.g., n=30 for tensile strength). This information is not provided in the 510(k) summary.
Data Provenance: The tests were performed internally by VitalCare Group, Inc., or by a contracted lab. The country of origin of the data is implicitly the USA (where the company is based and the submission was made). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate device performance and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a device like an IV administration set, "ground truth" as it relates to expert consensus in image analysis or clinical diagnosis is not relevant. The "ground truth" for performance is established by engineering specifications, material standards, and industry best practices. The "experts" would be the engineers and quality control personnel designing and testing the device, but their specific numbers and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for diagnostic or AI performance studies. This is not a human-in-the-loop or diagnostic device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is for evaluating human performance, often with and without AI assistance, typically in diagnostic or screening contexts. It is not relevant for an IV administration set.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device does not have an "algorithm" or AI component. It is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements for IV administration sets. This would include:

Physical specifications (e.g., dimensions, flow rates)
Material properties (e.g., tensile strength, chemical compatibility)
Biocompatibility standards (e.g., ISO 10993)
Sterility assurance (e.g., ISO 11135 for EO sterilization)
Leakage and connection integrity standards.

The 510(k) summary indicates that "Pull testing, pressure testing, joint strength testing, and drop testing has been performed," which are standard engineering tests to verify these aspects.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

K050906

AUG 23 2005

510(k) Summary VitalCare Group, Inc. 8935 NW 27th Street Miami. FL 33172 Tel 305-620-4007 Fax 305-620-9989 Contact: Ramzi Abulhaj, President Date: August 15, 2005

Device: "3 In 1" I V Administration Set I.

Common Name:	I. V. Administration Set
Classification Name:	Set, Administration, Intravascular
Panel:	General Hospital and Personal Use
Product Code:	FPA
Device Classification:	II

DEVICE DESCRIPTION II.

INTENDED USE OF THE DEVICE III.

The 3 in 1 IV Administration Set is used to administer fluids front a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.

{1}------------------------------------------------

KD50906

2

Comparison Table

Feature	Detail	PredicateK925465
Intended Use	The VitalCare 3 in 1 IV Administration Set is used toadminister fluids from a container to a patient's vascularsystem through a needle or catheter inserted into the vein.The device may include the tubing, a flow regulator, dripchamber, Y port, needleless injection port, backflow valve,fluid delivery tubing, connectors between parts of the set anda hollow spike to connect the tubing to an IV bag ormedication bag.	Identical
Components	Spike, ABS, Polylac PA-747Spike Cover, PELuer Locks, Male and Female, ABS, Polylac PA-747Luer Protective Covers, Polypropylene R701GPVC Tubing, Medical Grade DEHP free, 2228GBF-65SClearY Port/Split Septum, ABS, Polylac PA-747Needleless Y Port, ABS, Polylac PA-747Extension Tube, Medical Grade DEHP free PVC/ABS3 in 1 Flow Regulator, ABS, Polylac PA-747Back Flow Valve, ABS, Polylac PA-747Roller Clamp, ABS, Polylac PA-747Tube Clamp, ABS, Polylac PA-747Pouch, Polypropylene R701GKraft triple wall Corrugated fiberboard	Similarcomponents andmaterials
PerformanceTests	BiocompatibilityBench TestingSterilization/Residuals	Similar
Labeling	Reorder NumberSizeQuantityLot NumberSterileBar CodeDEHP FreeLatex FreeSingle Use OnlyPouch and Shipping caseManufacturer Address	Similar
Packaging	50 pouches per case	Similar
Sterilization	Sterile (EO)	Sterile (EO)

{2}------------------------------------------------

K050906

page 3 of 3

510(k) Summary VitalCare Group, Inc.

IV Performance Data

Pull testing, pressure testing, joint strength testing, and drop testing has been performed.

V. Conclusion

The VitalCare "3 in 1" IV Administration Set is substantially equivalent to the above products by having the identical indication for use and similar materials used for construction.

The materials used to manufacture the VitalCare IV Administration Set are used in legally marketed devices under comparable conditions.

Comparison of the predicate device to the VitalCare IV Administration Set for technological differences showed no significant difference.

VI. Description of the Marketed Equivalent Device:

Common Name:	IV Administration Set
Classification Name:	Set, Administration, Intravascular
Product Code:	FPA
Applicant:	Biomedix Inc.23 South Main StreetP. O. Box 231Spencer, IN 47460
Equivalent Device	K925465, IV Set

Intended Use of the Marketed Equivalent Device: VII

The Selec-3 is an adjustable 3 in 1 volume IV Set is used to administer fluids from a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, an infusion line filter, backflow valve an IV set stopcock, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines forming the body and head, and two curved lines representing the legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2005

VitalCare Group, Incorporated C/O Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K050906

Trade/Device Name: VitalCare I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 7, 2005 Received: July 7, 2005

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

{4}------------------------------------------------

Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Huang
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_VitalCare I. V. Administration Set

Indications For Use: The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.

Prescription Use V

AND/OR

Over-The-Counter Use

. . . . . . . . . . . . . . . . . . . . . . . . .

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintur ve, me

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:___________________________________________________________________

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.